Global Research in Paediatrics – Network of Excellence (GRiP)
The "Global Research in Paediatrics – Network of Excellence (GRiP)" is a network of scientists which aims to stimulate and facilitate the development and safe use of medicines in children. The main reason for the existence of GRiP is the lack of appropriate testing of paediatric drugs, with most drugs having inadequate information about dosing regimen, dose adjustment and administration. GRiP partners are working to build and maintain an infrastructure matrix, which has the core aim of reducing the current fragmentation of the efforts to study and develop the use of medicine in children. GRiP will mobilize 21 partners from Europe, North America and Japan, as well as the WHO. By linking the existing paediatric research networks, GRIP will involve more than 1000 institutions worldwide. GRiP aims to become the leading research network in the field of paediatric clinical pharmacology. The "Global Research in Paediatrics – Network of Excellence (GRiP)" is funded by the European Union under the Seventh Framework Programme. The funding started on 1 January 2011 and is expected to last until 31 December 2015.
The work of GRiP has been divided into nine Work Packages, each dealing with a fundamental aspect of the development of medicines for children. Pedianet enter into this project for the section concerning “Epidemiological and post-marketing studies” (WP2). The currently available pharmacoepidemiologic data on infants, children, and adolescents are not adequately utilised due to hindrances including:
1. the lack of a federation of databases for meaningful investigations 2. the lack of shared methodologies to specifically retrieve paediatric information 3. a lack of standardized methods and study designs. New methodologies and guidelines regarding the scope of pharmacoepidemiology in paediatric clinical drug and vaccine development are urgently needed.
To answer the call, Work Package 2 will target the following key areas:
Ø Build an online platform for real time data sharing and scientific collaboration as a basis of an integrated research infrastructure. Ø Identify healthcare databases with population based information on drug use and vaccine outcomes in children and to describe their characteristics. Ø Describe the governance and ethical issues related to the use and linking of the healthcare databases. Ø Map disease and drug/vaccine coding terminologies across the healthcare and adverse events databases Ø Create a common methodology for drug and vaccine utilization studies, for disease incidence and prevalence studies, and for epidemiological ascertainment of drug and vaccine safety. All of which using a distributed data model.
• Report on international adverse drug events (ADE) databases Lead Beneficiary – EMC Objective – Reported on the number and completeness of paediatric ADE data plus recommendations for EU, US and Japan to improve paediatric reporting.
• Description of Data Sources Lead Beneficiary – EMC Objective – Reported on the identified healthcare databases and their characteristics plus literature on their experience with respect to paediatric studies
• Integrated online research infrastructure Lead Beneficiary – EMC Abstract – This deliverable of the GRIP project describes the research infrastructure that will allow for collaborative work on aggregated healthcare data on paediatrics. The electronic infrastructure that has been built will allow for virtually linking existing healthcare databases across the globe to assess incidence/prevalence of diseases in children, plus the use and effects of drugs (including vaccines) on a large scale and in a standardized manner. The preferred work model in GRIP is a distributed approach, with standardized data elaboration nationally based on validated analytical scripts (JERBOA or SAS). The aggregated data will be shared on the remote research environment which is located within the firewalls of the Erasmus University Medical Center. Remote access and use is secured by personal tokens, use of the data will be under supervision of a data manager. This will allow all partners to analyse the data.